Spots Global Cancer Trial Database for A Phase 1 Study in Patients With HPV16+ Recurrent/ Metastatic Head and Neck Squamous Cell Carcinoma
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Trial Identification
Brief Title: A Phase 1 Study in Patients With HPV16+ Recurrent/ Metastatic Head and Neck Squamous Cell Carcinoma
Official Title: A Phase1, First-in-Human, Open-Label, Dose Escalation and Expansion Study of CUE-101 Monotherapy in Second Line or CUE-101 Combination Therapy With Pembrolizumab in First Line Patients With HPV16+ Recurrent/Metastatic HNSCC
Study ID: NCT03978689
Study Description
Brief Summary: This is a multi-center, open-label, phase 1 dose escalation and expansion study evaluating the safety, anti-tumor effect, and immunogenicity of CUE-101 as monotherapy treatment in second line or CUE-101 Combination Therapy with Pembrolizumab in first line patients with HPV16+ Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma (HNSCC)
Detailed Description: CUE-101 is a novel fusion protein designed to activate and expand a population of tumor specific T cells to eradicate human papilloma virus (HPV)-driven malignancies. HPV causes multiple tumor types including cervical, head and neck squamous cell carcinoma (HNSCC) and anal cancers. Initial testing of CUE-101 will be conducted in HPV16+ HNSCC patients. The primary objectives of the Part A\&B, first-in-human trial, are to assess the safety and tolerability of CUE-101 in subjects with recurrent/metastatic HNSCC in the second line setting and to determine the maximum tolerated dose or recommended Phase 2 dose based on markers of biological activity. Pharmacokinetics (PK), antitumor immune response, preliminary antitumor activity and the potential for immunogenicity will also be assessed. The goal of Part C\&D is to characterize the safety, tolerability, and biological effects of CUE-101 in combination with pembrolizumab in patients with recurrent/metastatic HNSCC in the first line setting. This will be an open-label multicenter phase I trial conducted in the U.S. involving approximately 85 patients.
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
University of Arizona, Tucson, Arizona, United States
Stanford University Medical Center, Palo Alto, California, United States
Yale School of Medicine, New Haven, Connecticut, United States
George Washington University Cancer Center, Washington, District of Columbia, United States
Moffitt Cancer Center, Tampa, Florida, United States
Emory University School of Medicine, Atlanta, Georgia, United States
Affiliated Oncologists, LLC, Chicago, Illinois, United States
Johns Hopkins Sidney Kimmel Comprehensive Cancer Center, Baltimore, Maryland, United States
Massachusetts General Hospital, Boston, Massachusetts, United States
University of Michigan, Ann Arbor, Michigan, United States
Barbara Karmanos Cancer Center/ Wayne State University School of Medicine, Detroit, Michigan, United States
Washington University, Saint Louis, Missouri, United States
Memorial Sloan Kettering Cancer Center, New York, New York, United States
Gabrail Cancer Center, Canton, Ohio, United States
Vanderbilt-Ingram Cancer Center (VICC), Nashville, Tennessee, United States
University of Texas MD Anderson Cancer Center, Houston, Texas, United States
University of Washington School of Medicine, Seattle, Washington, United States
Contact Details
Name: Matteo Levisetti, MD
Affiliation: Cue Biopharma
Role: STUDY_DIRECTOR
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